Continuing our history of Alar from last week (and filling in a few more details prior to 1986):

Alar is a growth-regulating hormone sprayed on apples to hold them on the tree longer and reduce bruising. Keeping apples on the tree longer darkens their red color, making consumers happy. Alar therefore provides economic benefits to apple growers, who can harvest their crop during a 5-week period instead of a 3-week period (which reduces their labor troubles, among other benefits).[1] The benefit to consumers is a cosmetically- enhanced apple that stays a bit crunchier a bit longer. Alar was voluntarily withdrawn from the U.S. market by its manufacturer, Uniroyal Chemical corporation, in 1989 after 10 years of controversy.

Despite the benefits of Alar, studies in 1967, 1973, 1977, 1978, and 1979 indicated that Alar (and its contaminant and breakdown byproduct, UDMH) causes several kinds of cancer in both sexes of two species of animals, mice and hamsters. There is also evidence of cancer in a third species, rats, exposed to Alar in a study conducted by the National Cancer Institute in 1978.[2]

By the early 1980s, the public health community had reached agreement that Alar/UDMH causes cancer in laboratory animals and is a "probable human carcinogen:"

** The International Agency for Research on Cancer (IARC) in Lyon, France, listed UDMH as a probable human carcinogen in 1982.[3]

** The Carcinogen Assessment Group within U.S. Environmental Protection Agency (EPA) in January, 1984 reached this same conclusion, and calculated a cancer potency number for UDMH.[4]

** The U.S.'s National Toxicology Program (NTP) in its 1984 report to Congress listed UDMH in the category, "may reasonably be anticipated to be carcinogens." The NTP's 1984 statement on UDMH began, "There is sufficient evidence for the carcinogenicity of 1,1-dimethyl hydrazine (UDMH) in experimental animals."[5] At that time, the NTP report was a consensus statement by nine U.S. federal agencies: Centers for Disease Control; National Institute for Occupational Safety and Health; Consumer Product Safety Commission; EPA; Food and Drug Administration (FDA); National Cancer Institute; National Institute of Environmental Health Sciences; National Library of Medicine; Occupational Safety and Health Administration.

During 1985, EPA hired independent auditors to visit the laboratory of Bela Toth at University of Nebraska to check his work. It was Toth who had conducted the 3 screening studies that had first revealed carcinogenicity of Alar/UDMH in mice and hamsters. The auditors criticized some of Toth's laboratory practices but in each case they concluded that the basic finding of carcinogenicity was supportable.[6]

In late summer, 1985, EPA announced it was preparing to ban Alar from use on food crops (its use on flowers would continue). EPA submitted its proposed ban plan to the 8-member Science Advisory Panel (SAP) established by federal law. The SAP held a one-day meeting and concluded, "The Toth Alar studies do give rise to concern over the potential oncogenicity of daminozide [Alar]."[7] Oncogenicity is the ability to cause tumors. However, the SAP said, the available studies would not permit EPA to calculate the SIZE of the cancer hazard posed by Alar and UDMH in food. If this were true, the legal effort to ban Alar would be an uphill battle.

The judgment of the SAP itself may have had a political bias. A Senate oversight subcommittee revealed that 7 of the 8 members of the SAP had been "paid consultants to the chemical industry or to organizations supported by the chemical industry at the time they served on the [Alar-decision] panel." At least one member of the SAP developed a direct financial connection to Uniroyal, Alar's manufacturer, shortly after the SAP rendered judgment on the Alar data. Uniroyal hired Chris Wilkinson a few months after he left the SAP, and sent him back to Washington to lobby EPA scientists on Uniroyal's behalf, trying (unsuccessfully) to alter the protocols that EPA had set for Uniroyal's mouse studies of Alar.[8] Neither Wilkinson nor Uniroyal saw anything wrong with such a revolving door arrangement.

EPA was not required by law to follow the recommendations of the SAP, and EPA staff scientists disagreed with the SAP conclusion, but this was a political matter, to be judged at the highest levels of EPA. In January, 1986, EPA announced it would not seek to ban Alar, but would require apple growers to reduce its use by 50%, and would require Uniroyal, for the first time, to conduct its own studies of the carcinogenicity of Alar. Alar had then been on the market for 18 years and Uniroyal had never studied its carcinogenicity. Uniroyal says it has studied the health of its manufacturing workers exposed to Alar and found no problems, but the company refuses to release the data from those studies.[1]

Entering 1986, Alar was still legal but had fallen under a pretty severe cloud. During 1986, the following events occurred:

** Gerber, the baby food manufacturer, announced finding Alar in its apple juice and apple sauce.

** The makers of Mott's apple products, Veryfine apple juice, and Red Cheek apple juice, among others, announced they would not accept Alar-treated apples.[9]

** The Washington Apple Commission urged apple growers in the state of Washington to stop using Alar.[10] More than half the nation's apple crop is grown in Washington state.

** The State of Massachusetts passed legislation to phase out (by 1988) the use of Alar for apples that would later be processed and/or used for infant or baby foods.[1]

** The State of Maine followed the example of Massachusetts, but restricted the use of Alar even more rapidly, by October, 1986.[1]

** Despite its continuous claims of safety for Alar, Uniroyal voluntarily sent an advisory to apple processors recommending that Alar-treated apples not be used for apple sauce because its intensive processing might cause Alar to release UDMH.[9]

** At least four of the country's major grocery chains notified their apple suppliers that they would no longer accept apples treated with Alar. Safeway, the nation's largest chain; Kroger, the second-largest; Giant, the biggest chain in the Washington, D.C., area; and Grand Union, in the New York area pledged to stop stocking Alar-treated apples.[11]

Events of 1987

** In January, 1987, EPA's Carcinogen Assessment Group (CAG) did what the Science Advisory Panel (SAP) in 1985 had said couldn't be done (and which the CAG had previously done in 1984[4]): CAG developed a quantitative estimate of the cancer potency of Alar/UDMH.[12] This was the cancer potency estimate used in 1989 by Natural Resources Defense Council (NRDC) in its now-famous report, INTOLERABLE RISK: PESTICIDES IN OUR CHILDREN'S FOOD.

** In March, NRDC, Ralph Nader, the State of New York, the Maine Department of Human Services, several pediatricians, and several children, filed suit in the U.S. Court of Appeals in San Francisco to try to force EPA to ban Alar. This same group had petitioned EPA in 1986 to ban Alar, but the agency had refused.

** By now, NRDC has initiated a study of the hazards of 23 pesticides in the diet of American children during the first 6 years of life, focusing on three things: (a) the cancer hazard; (b) toxicity to the central nervous system; (c) inadequate protection of public health provided by a pesticide regulatory system that seems incapable of responding in a timely way to widely-acknowledged chemical hazards. This is the study that will eventually be accused of creating the "Alar scare." The fuse is lit.

We all know --or think we know --the story of Alar, the apple pesticide. We all know that the "Alar scare" of 1989 was a toxic false alarm, a hoax based on junk science perpetrated by Natural Resources Defense Council (NRDC), Consumer's Union (CU), CBS's "Sixty Minutes" news show, and the movie star Meryl Streep. Alar was in fact a safe chemical, essential for the economic health of the nation's apple industry, but it was suddenly and unexpectedly pulled from the market after environmental and consumer extremists created a sudden storm of frightening publicity in 1989. As a result, the apple industry had to abandon an essential crop protection tool and consequently suffered losses of at least $100 million. Or so the story goes.

This rendition of the Alar story has been told and retold so many times since 1989 that we have all come to believe it. And the story keeps being repeated like a drum beat right up to the present. The [Phoenix] ARIZONA REPUBLIC April 21, 1995, called the Alar scare a "false alarm." The PROVIDENCE [Rhode Island] JOURNAL-BULLETIN said May 6, 1995, "Alar crisis of 1989... it was soon found that there was no scientific evidence of any harm Alar had done to anyone." The WALL STREET JOURNAL May 7, 1995, referred to the "1989 Alar-on-apples uproar that practically destroyed the reputation of apples as good food using questionable scientific evidence." The RICHMOND (Virginia) TIMES-DISPATCH March 31, 1996 (pg. F6) referred to the "bogus Alar scare of 1989." The Madison, Wisconsin STATE JOURNAL May 17, 1996 (pg. 13A) referred to the "ridiculous Alar scare." The NEW YORK TIMES said October 26, 1996 (pg. 39), "Since the Natural Resources Defense Council warned the public in 1989 about the elevated cancer risk from pesticides like Alar--a scare that turned out to be overblown--there has been heightened anxiety about conventionally cultivated food." The Albany, New York TIMES UNION said November 13, 1996 (pg. B1), "The Alar scare is now widely agreed to have been overblown..." The SAN JOSE [California] MERCURY NEWS November 14, 1996 (pg. B11), said, "In 1989, the Alar scare cost apple growers an estimated $100 million."

This is a tiny sample of recent re-statements of the Alar story in major newspapers.[1] Unfortunately, all of them are untrue.

The true story of our awakening to the hazards of Alar begins in 1973. The Uniroyal corporation had received a government license to sell Alar for use on apples and peanuts in 1968. Back in those days, U.S. Department of Agriculture (USDA) had legal responsibility for the health and safety aspects of all crop chemicals. Between 1945 and 1966, USDA licensed nearly 60,000 individual pesticides at a time when the agency had only one toxicologist on staff; it was his job to keep abreast of the health and safety literature (if any existed) for each of the 60,000 products.[2] (To help get the size of his task into perspective, U.S. EPA set out in 1972 to examine the health and safety aspects of all 60,000 pesticides; the agency recently announced that it hopes to complete the job in the year 2010.[3]) Therefore, it seems safe to say that the health effects of Alar had been evaluated poorly, if at all, when the chemical first began appearing on the apples in your grocery store in 1969.

Alar is a "growth regulator." It doesn't kill pests, but it prevents fruit from dropping to the ground too early. As a result, it allows apple growers to harvest their crop all at one time, and it makes apples more firm, more resistant to bruises. It also prolongs the shelf life of the fruit, and it darkens the red in apples, giving Alar-sprayed fruit a cosmetic advantage. For all these reasons Alar quickly became very popular with apple growers.

Alar is manufactured by reacting succinic anhydride with 1,1,dimethylhydrazine (UDMH), a toxic component of rocket fuel. Therefore UDMH has always been a contaminant present in Alar.[4] Furthermore, Alar degrades into UDMH when it is heated --as in cooking apple sauce, or sterilizing apple juice for bottling --or when Alar is digested in the human stomach.[5] In tests of carcinogenicity [cancer-causing power], UDMH proves to be about 1000 times as powerful as Alar itself. So when we discuss the dangers of Alar, we are always necessarily discussing the dangers of Alar and UDMH combined.

For its part, Uniroyal has always played down the inherent dangers of Alar/UDMH. In one formulation the product was marketed under the name B-Nine. Benign, get it?

The benign image of Alar began to erode in 1973, when a study published in the JOURNAL OF THE NATIONAL CANCER INSTITUTE showed that mice given UDMH at high levels in their drinking water developed cancer of the lung, kidney, liver, lymph system, and blood vessels.[6]

A follow-up study of mice published in 1977 confirmed the finding of cancer in the lungs, kidneys, and blood vessels of treated mice. Also published in 1977 was a study of Alar's effect on Golden hamsters, which reported rare blood vessel tumors in both sexes, and tumors of the intestines in both sexes.[7] Benign it was not.

At that time, U.S. Environmental Protection Agency [EPA] had an obligation under law (the so-called Delaney clause) to ban pesticides known to cause cancer in animals or humans if those pesticides concentrated in processed food, such as apple sauce and apple juice. The 1977 studies put Alar/UDMH squarely into the category of chemicals regulated by the Delaney clause. EPA was required to ban it. However, the agency took no action against Alar for the next seven years. (Congress repealed the Delaney clause in 1996.)

On September 19, 1984, U.S. EPA announced that it was investigating the lifetime cancer risks among people eating apples and peanuts sprayed with Alar.[8]

Almost a year later, in August, 1985, EPA announced that it was planning to initiate a process that would result in banning Alar. Such a process might take a decade or even longer.[9]

In 1985, EPA reasoned as follows: Alar was being used on 38% of the U.S. apple crop; it penetrated to the interior of the apple so washing wouldn't remove it; and it might be causing as many as 100 cancers per million people exposed to it in their diet for a lifetime. The official threshold for concern within EPA at that time was one cancer in a million exposed people, so Alar was thought to create a human health hazard at least 100 times as great as the agency considered acceptable.

EPA submitted its Alar ban plan to its Scientific Advisory Board (SAB) in the fall of 1985. At that time, if EPA wanted to ban a pesticide, the burden was on the agency to prove that the ban was scientifically, provably warranted. (This is still true today.) Furthermore, if EPA succeeded in banning a pesticide, the agency was responsible for reimbursing the manufacturer of the chemical for the cost of the remaining stocks of the banned chemical. Under law, it was up to the EPA to purchase, transport, and dispose of banned pesticides. For example, EPA paid the manufacturers of the herbicide 2,4,5-T $20 million when 2,4,5-T was banned, and EPA paid $40 million to the manufacturer of Dinoseb when it was banned.[10] At that time, the entire yearly budget of EPA's Office of Pesticide Programs was only $60 million, so banning a pesticide could seriously deplete the agency's operating funds. A ban was not something that could be undertaken lightly. (In 1988, Congress removed this financial burden from EPA.)

On January 14, 1986, the National Food Processors Association (NFPA) announced that its own tests had detected Alar in 73 samples of apple sauce and 132 samples of apple juice.[11] NFPA had started testing food from grocery stores when EPA had first announced its concerns about Alar and cancer in 1984. Simultaneously, Gerber, the largest manufacturer of baby food, announced finding Alar in its apple juice and apple sauce.

A week after Gerber and NFPA announced finding Alar in baby food and juice, EPA announced that it had changed its mind and would not seek a ban on Alar because the SAB wanted more studies.[12] SAB felt the 1973 and 1977 studies were now too old to form the scientific underpinnings of a major political/legal fight, such as a pesticide ban.

However, while announcing that it was backing off its announced ban plan, EPA said it would seek a 50% reduction in the levels of Alar allowed to remain on apples as they leave the orchard.

At this point the public has a right to be confused and alarmed: at least three studies have shown Alar/UDMH to be a potent carcinogen in both sexes of two animal species. EPA has published its rough assessment that Alar is 100 times more dangerous than is allowed by agency standards. The agency has announced it will seek a ban, then backed off saying it will insist on a 50% reduction in toxic residues on apples. Meanwhile major food marketing organizations --including Gerber --have announced finding Alar in apple sauce and apple juice, which are staples in the diets of most babies. The stage seems set for the "Alar scare" to erupt in the media. But in our story we've only reached 1986 and the "scare" is still 3 years away.

The toxic metal, lead, is associated with aggressive behavior, delinquency, and attention disorders in boys between the ages of 7 and 11, according to a study by Herbert Needleman published in 1996 in the JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (JAMA).[1] Aggressive behavior, delinquency and attention disorders in youth are, themselves, predictors of criminal behavior later in life.[2] This is not the first study linking lead exposure to behavioral disorders, but it is one of the most carefully done.

Needleman's study examined 301 boys in public schools in Pittsburgh, Pennsylvania, measuring the lead in their bones and relating it to behaviors reported by the boys' teachers and parents, and by the boys themselves. Boys with more lead in their bones consistently had more reports of aggressive and delinquent behavior, and problems paying attention. The boys' behavior was measured at age 7 and again at age 11, and the behavior of boys with more lead in their bones got worse as they grew older; on the other hand, behavior did not change among boys with less lead in their bones.

Aggressive behavior, delinquency, and attention disorders in boys and young men are also associated with poverty, minority status, and disorganized homes, so lead is not the only factor at work in many cases. However, the 1996 Needleman study examined 9 variables in addition to lead (such as parent's socioeconomic status, mother's age, presence or absence of a father in the home, and so forth), to see if they might explain the boys' behavior. The relationship between lead and behavior disorders held up.

"These data argue that environmental lead exposure, a preventable occurrence, should be included when considering the many factors contributing to delinquent behavior," the authors of the study said.

What is remarkable is the degree to which environmental lead exposure has been ignored in the past by people concerned about the growing problem of aggressive, anti-social behavior in boys and young men in the U.S. An estimated 20% of American children now exhibit mental or behavioral problems.[3] As early as 1943, Randolph Byers and Elizabeth Lord[4] examined 20 children who had recovered from "mild lead poisoning in infancy." They reported that none of the children had exhibited overt signs of lead poisoning, yet the growth and development of their nervous systems had been "seriously impaired." Among the 20 children examined, only one had progressed satisfactorily in school. Furthermore, many of the children were emotionally impaired as well. Byers and Lord characterized the behavior of many of the children as "unreliable impulsive behavior, cruel impulsive behavior, short attention span, and the like." Three of the 20 children were expelled from school, one for setting fires, another for repeatedly getting up and dancing on the desks, and a third for sticking a fork into another child's face. In 1986, Byers recalled that others in the group he had studied in 1943 had attacked teachers with knives and scissors.[5] Byers's 1943 report should have set off alarm bells, but it didn't.

After the 1943 report, for the most part lead researchers ignored the newly-revealed connection between lead, aggressive behavior and impaired attention. Instead they went on to demonstrate conclusively that intellectual power (as measured by IQ) was consistently reduced by exposure to low levels of lead. For every 10 microgram rise (in each deciliter of blood), there is a 6 point loss of IQ.[6] [A deciliter is a 10th of a liter, and a liter is about a quart.] Reduced IQ power can be measured when lead is as low as 7 micrograms per deciliter of blood (7 ug/dl).[7] In fact, there is no apparent threshold for this effect: any amount of lead seems to diminish mental power in children.[8] Furthermore, brain damage from lead exposure persists for many years; the IQ reduction caused by lead in childhood is essentially permanent.[9]

Nevertheless, some work on lead and behavioral disorders did appear:[10]

** In Virginia in 1975, researchers compared 67 lead-exposed 7-year-olds to 70 non-exposed children to see if lead exposure was related to increased behavior problems in school.[11] Nineteen of the lead-exposed children were described as "hyperactive, impulsive, and explosive, and as having frequent temper tantrums." Only five among the non-exposed group were described this way.

The group was re-evaluated a year later, emphasizing behavior in the home. The examination of 8-year-olds revealed 14 lead-exposed children with "severe abnormalities," defined as lying, stealing, running away, and setting fires, vs. six with such abnormalities among the non-exposed group.

** In rural Tennessee in 1982, researchers asked teachers to identify "problem children" among their students, using the Walker Problem Behavior Identification Checklist, a screening device designed for elementary school teachers to help them identify troubled kids. Average lead levels in the hair of 26 "problem children" was nearly twice as high (11.6 ppm vs. 6.5 ppm) as in a control group of 29 students identified as not having problems.[12]

** In Scotland in 1989, researchers showed that lead was related to attention disorders and aggressive behavior (as reported by parents and teachers) among a group of 501 students between the ages of six and nine. These children had average (mean) blood lead levels of 10.4 ug/dl.[13]

** In Baltimore in 1992, blood lead levels among 201 African-American children aged two to five were compared to the children's behavior as reported by their mothers on a well-known standardized questionnaire (the Child Behavior Checklist, or CBCL).[14] Of these, 123 were in the "high exposure" group (blood lead levels of 15 ug/dl, or more) and 78 were in a "low exposure" group. The high-lead group consistently had more maternal-reported troublesome behaviors. For example, 8.1% of the high-lead group were "aggressive" vs. 1.4% in the low-lead group. Mothers reported 4.1% of the high-lead children had "destructive" behavior vs. no such behavior in the low-lead group.

** In New Zealand in 1993, researchers examined lead in the teeth of 1265 children aged 6-8, compared to behavior of those children as measured seven years later.[15] They found a small but consistent relationship between increasing lead and increasing social adjustment problems in youngsters.

** In Boston in 1994, a study of 1782 children related the amount of lead in their teeth to behavior in school (using the CBCL).[3] Problem behaviors increased systematically as lead levels in the children's teeth increased.

In recent years, lead in the blood of Americans has diminished substantially, because the government outlawed lead in gasoline and lead in tinned cans used for food.[16] The biggest reduction has occurred among white children, but all populations have benefitted to some extent. Nevertheless, in 1994, an estimated 1.7 million American children between the ages of one and five (mostly African Americans living in large cities) had average blood lead levels of 10 ug/dl or more, and a million children had blood lead levels of 15 ug/dl or more. Among African American children in large cities, 36.7% have blood lead levels above 10 ug/dl, and 17.0% of Mexican-American children in large cities have similar levels of toxic lead in their blood.[17]

In the mid-1970s, 40% of American children under age 5 had average (mean) lead levels of 20 ug/dl or more.[18] Among African-American children in the mid-1970s, more than half had blood-lead levels greater than 15 ug/dl.[16] This is the generation that is presently in its mid-20s. How is this generation doing?

In 1993, 1.53 million Americans were in jail or prison --triple the number that had been incarcerated in 1980.[19] In 1980, one in every 453 Americans was in state or federal prison; by 1993, the number had risen to one in every 189.[20] In 1993, the incarceration rate among blacks was seven times as high as among whites. Between 1990 and 1993, the number of drug offenders increased dramatically by 55,500, but the number of violent offenders grew even more rapidly (by 82,100). In 1994, the prison/jail population increased at the rate of 1600 each week and almost 1200 (75%) of these new inmates were black or hispanic.

It seems possible that the observed connection between brain-damaging lead and destructive behavior explains a portion of these increases.[21]

Prevention is the key. The main source of the toxic lead in children today is dust and soil,[22] but the source of the lead in the dust and soil is lead-based paint coming out of older buildings.[23] The federal Centers for Disease Control (CDC) in Atlanta has calculated the cost of removing all lead-based paint from old buildings, along with the benefits that society would realize from such a removal (reduced costs for medical care and for special education, plus increased salaries that go with higher IQs). According to CDC, American taxpayers would realize a net profit of $28 billion by removing all lead-based paint.[24]